Doctor using laptop computer updates the electronic health record of patient

The FDA first drafted guidance on CDS software in 2017, but finalizing it has not been a priority for the agency since.

Changes Coming Next Year

In late October 2021, the FDA’s Center for Devices and Radiological Health released proposed guidance documents for fiscal year 2022, with clinical decision support software topping the “A-list.” Clarifying rules for software and artificial intelligence applications in healthcare are evidently of growing importance to the FDA—four of the FDA’s highest priorities in the coming year involve software.

To date, the FDA has used their enforcement discretion not to regulate CDS software. That’s largely because CDS software has emerged in nascent stages as a form of telehealth and artificial intelligence platforms asking patients general questions about their health.

An example would be software that asks a patients questions about symptoms they’re having, if the patient is taking any medication, if there is any pain or discomfort, etc. These CDS software applications serve largely as a means for information gathering, where the patient may ultimately be advised to make an appointment with a doctor. If the diagnosis and treatment are ultimately made by a doctor, it falls outside of the FDA’s purview—the agency does not regulate the practice of medicine as long as its practiced by a person.

The potential of CDS software extends beyond general health, however. It is by no means a stretch of the imagination to consider the possibility of software making a diagnosis based on detailed information provided by a patient. The issue gets very thorny once the software tells a patient they have a problem they don’t actually have, or if a patient is told everything is fine when there is actually a missed diagnosis. These outcomes pose not only a major regulatory issue, but also a massive liability issue for companies developing the technology.

On a more rudimentary level, another CDS software example might be a patient arriving at the ER and being directed to a kiosk, where they are asked virtually the same questions a physician would ask in person. Would the FDA regulate this use of CDS software? Potentially yes, since it’s open to interpretation that medicine is not being practiced by a person in that instance.

The FDA’s prioritization of CDS software guidance may also be the agency sensing a coming proliferation of new products, online tools, and software applications that meet the Code of Federal Regulation’s definition of a medical device. More products and software applications may mean greater possibility that future products could provide wrong and/or inaccurate information, which is what may be spurring the agency to take a more proactive approach. There have also been recent examples in the press of software tools frequently giving false positives, like Epic’s algorithm designed to predict which patients might develop sepsis.

In the FDA’s most recent proposed draft of CDS software guidance—which is a 2019 revision of the original 2017 document—the agency hinted at expanding its oversight of algorithms used to treat serious conditions. There may also be scrutiny on software where a clinician cannot review the basis for the algorithms suggestion.

There are already three areas in the CDS software that are largely not exempt from the FDA’s enforcement discretion:

  1. The CDS software cannot be used to process or analyze a medical image or signal from an in-vitro diagnostic
  2. The software displays, analyzes, or prints medical information about a patient
  3. It is intended to support or provide recommendations to a healthcare professional regarding how to diagnose or treat a condition/disease

With the coming guidance in 2022, it remains to be seen how and if the FDA intends to expand its oversight. A key clarification will be in determining when a CDS meets the definition of a medical device, and how medical device requirements will ultimately apply to software. After all, hardware is very different than software.

The general feeling in the medical device and health IT space appears to be relief the FDA is finally prioritizing CDS software guidance, which has been over five years in the making. There are opposing concerns, too, like the American Hospital Association’s worry that existing algorithms would now be subject to the FDA approval process.

Regardless of the outcome, 2022 will certainly be a crucial year for software in the healthcare sector, with particular attention being placed on the top priority: CDS software. Other items to watch will be guidance around cybersecurity for medical device developers, as well as a transition plan for devices that received emergency use authorization during the pandemic.